MAUDE Adverse Event Report: K2M, INC. ANGLED LATERAL INSERTER; 25; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SP-3140
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aleutian lateral inserter would not disengage from an implant during intra-operative cage placement.There were no reported adverse consequences to the patient.The procedure was completed successfully using an alternative inserter with a 30 minute surgical delay.This report captures the inserter.
Additional Manufacturer Narrative
Correction to d2: product code was corrected from 'max' to 'lxh' and common device name was corrected from 'intervertebral fusion device with bone graft, lumbar22' to 'orthopedic manual surgical instrument.' correction to g4: a pma# was provide in the initial mdr, however, this device is not pma approved.Visual inspection: the device was inspected and was confirmed to have been unable to disengage from an implant.The inserter tip was jammed with the interbody and was unable to be disconnected without the use of excessive force.Damage was identified at the inserter tip as it appears that both tabs were flattened/deformed.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.The damage to the device appears to be caused by excessive force during device implantation.It is possible that the user was twisting the instrument during implantation, which applied more pressure to the assembly and damaged the instrument.This high pressure could have compressed and crushed the tabs of the inserter between the instrument and the implant in the manner that was shown.As a result, the alleged failure mode was confirmed, and the most likely root cause of the issue was determined to have been excessive tightening force.
Event or Problem Description
It was reported that an aleutian lateral inserter would not disengage from an implant during intra-operative cage placement.There were no reported adverse consequences to the patient.The procedure was completed successfully using an alternative inserter with a 30 minute surgical delay.This report captures the inserter.

• Brand Name: ANGLED LATERAL INSERTER; 25
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10438688
• Report Number: 3004774118-2020-00184
• Device Sequence Number: 16779831
• Product Code: LXH
• UDI-Device Identifier: 10888857421080
• UDI-Public: 10888857421080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: SP-3140
• Device Catalogue Number: SP-3140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1